Actively Recruiting
A Study of Tetrathiomolybdate (TM) Plus Capecitabine
Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-04-20
204
Participants Needed
3
Research Sites
604 weeks
Total Duration
On this page
Sponsors
D
Dartmouth-Hitchcock Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
There are two parts to this study. It is a phase 1b followed by a randomized phase 2 study to assess whether adding 3 years of adjuvant tetrathiomolybdate (TM) to standard 6 months treatment of adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer. In the phase 1b part of the study, TM is added to adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer (RCB 2, 3, risk for relapse \>60% at 5 years) after completion of neoadjuvant chemo-immunotherapy and surgery to establish the safety of the combination. This will be followed by a randomized phase 2 clinical trial of adjuvant TM and capecitabine vs capecitabine alone. If pembrolizumab was administered in the neoadjuvant setting, it may be continued in the adjuvant setting per investigator discretion.
CONDITIONS
Official Title
A Study of Tetrathiomolybdate (TM) Plus Capecitabine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed triple negative breast cancer with ER and PR <1% and HER2 negative
- Completed at least 6 cycles of standard neoadjuvant chemotherapy
- Residual invasive carcinoma at node positive disease or RCB 2 or RCB 3 status after treatment
- Local therapy completed with negative margins and appropriate lymph node surgery
- Radiation therapy completed if lumpectomy performed, per investigator choice for chest wall
- Neoadjuvant pembrolizumab required for phase 1b and planned continuation in adjuvant setting
- At least 2 weeks since last chemotherapy or radiation, and 4 weeks since most recent surgery
- No clinical or radiologic evidence of disease after surgery and systemic treatment
- No prior treatment with capecitabine
- Age between 18 and 80 years
- Karnofsky Performance Status (KPS) of 90 or 100
- Life expectancy greater than 3 months
- Normal organ and marrow function with specific lab value thresholds
- Stable medical therapy for chemotherapy induced peripheral neuropathy if applicable
- Agree to use effective contraception during study participation
- Ability to understand and willing to sign informed consent
- Normal vitamin B12 levels
- Antiresorptive therapy and denosumab allowed
You will not qualify if you...
- Chemotherapy or radiotherapy within 2 weeks prior to study entry
- Surgery within 4 weeks prior to study entry
- Prior treatment with capecitabine or current use of warfarin
- Final breast surgery more than 12 weeks before study start
- For phase 1b, lack of prior neoadjuvant immunotherapy or no plan to continue it
- Evidence of active breast cancer or metastatic disease
- Carcinomatous meningitis or active brain metastases
- Creatinine clearance below 60 ml/min
- Allergic reactions to compounds similar to TM or capecitabine
- Pregnancy or breastfeeding
- HIV positive patients on combination antiretroviral therapy due to interactions with TM
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
2
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
3
NYU Langone perimutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
Research Team
R
Raven J Lavoie, RN
CONTACT
N
Naomi Kornhauser, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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